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Diss Factsheets
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EC number: 215-475-1 | CAS number: 1327-36-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity).
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- - only male animals; only three animals in negative control group; only 500 cells evaluated for mitotic index; no bone marrow toxicity in highest concentration used
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): synthetic silica sodium silicoaluminate (FDA 71-45)
- Physical state: fine white powder
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 300 to 350 g
- Housing: Rats were housed one to five per cage.
- Diet (e.g. ad libitum): commercial 4 % fat diet; periodic tests to verify the absence of coliforms, Salmonella and Pseudomonas sp. were performed.
- Water (e.g. ad libitum): water; 2 times per week water was changed
- Quarantine: 4 to 11 days
- Others: Animals were identified by ear punch. Sanitary cages and bedding were changed two times per week.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- saline (0.85 %)
- Duration of treatment / exposure:
- acute study: single dose (post exposure period: up to 48 hours)
subacute study: five days - Frequency of treatment:
- acute study: single dose
subacute study: 5 doses, daily - Post exposure period:
- acute study: sampling times 6, 24 and 48 h after administration of test substance
subacute study: animals were sacrificed 6 hours after the last dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
acute + subacute: 4.25, 42.5, 425 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5; only 3 animals in negative control group
acute study: 59
subacute study: 18 - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 0.3 mg/kg triethylene melamine (TEM) administered intraperitoneally
Examinations
- Tissues and cell types examined:
- freshly isolated bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The dose of 425 mg/kg corresponds to the LD5.
DETAILS OF SLIDE PREPARATION: Fixed cells were dropped on slides and dried. Slides were stained using a 5% Giemsa solution, subsequently rinsed with acetone/xylene and placed in xylene for 30 min before counting.
METHOD OF ANALYSIS:
Duplicate slides were examined microscopically. Only diploid cells were analyzed.
OTHER: 2 h prior to killing, each animal was given 4 mg/kg of colcemid intraperitoneally. - Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- LD5 = 425 mg/kg
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The compound produced no detectable significant aberration of the bone marrow metaphase chromosomes of rats when administered orally at the tested dosage levels. The test compound can be considered non-mutagenic.
Any other information on results incl. tables
acute study: The negative controls and the 3 compound-treated groups were within the normal limits of breaks observed (0 -3 %). The mitotic indices were in good agreement except for the 425 mg/kg group which was slightly, but not significantly, depressed. In the positive control group 5 % of the cells with severe damage (> 10 aberrations/cell) and 1% of the cells with pulverized chromosomes were observed.
Dose [mg/kg] |
Sampling time [h] |
Mitotic index [%] |
Cells with aberrations [%] |
0 (saline) |
6 |
10 |
2 |
24 |
11 |
3 |
|
48 |
9 |
3 |
|
4.25 |
6 |
11 |
2 |
24 |
11 |
1 |
|
48 |
11 |
3 |
|
42.5 |
6 |
8 |
0 |
24 |
9 |
1 |
|
48 |
10 |
0 |
|
425 |
6 |
12 |
2 |
24 |
6 |
0 |
|
48 |
10 |
2 |
|
TEM 0.3 |
48 |
3 |
48 |
subacute study: The negative control groups and the three treated groups were within normal limits for breaks and mitotic indices.
Dose [mg/kg] |
Mitotic index [%] |
Cells with aberrations [%] |
0 (saline) |
8 |
3 |
4.25 |
10 |
2 |
42.5 |
11 |
2 |
425 |
8 |
3 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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